Dia-X Sil Bite
K号: K254112 · 2026-03-19
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决定日期2026-03-19
产品代码ELW
咨询委员会DE
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决定实质等同
器械摘要
Dia-X Sil Bite is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K254112. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dia-X Sil Bite?
Dia-X Sil Bite is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is DiaDent Group International. The 510(k) number is K254112.
When did Dia-X Sil Bite receive FDA 510(k) clearance?
Dia-X Sil Bite received FDA 510(k) clearance on 2026-03-19, under 510(k) number K254112.
Who is the listed applicant for Dia-X Sil Bite?
FDA 510(k)记录显示DiaDent Group International为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Dia-X Sil Bite?
The FDA product code for Dia-X Sil Bite is ELW.
列明DiaDent Group International为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：ELW）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254142迪亚-X 硅重体DiaDent Group InternationalK254152Dia-X Sil Light BodyDiaDent Group InternationalK253501Hydro Print Premium 快速设置 - 454g (1lb) (052037)；Hydro Print Premium 标准设置 - 454g (1lb) (052327)；Chroma Print Premium 快速设置 - 454g (1lb) (052457)；Chroma Print Premium 标准设置 - 454g (1lb) (051460)；Perfil Pro - 454g (1lb) (056213)；Perfil Pro+ - 454g (1lb) (056121)；Perfil Pro Chroma - 454g (1lb) (056122)；Hydro Print Premium 快速设置 - 多包装 (056205)；Hydro Print Premium 标准设置 - 多包装 (056208)；Hydro Print Premium 快速设置 - 9,07Kg (20lb) (056204)；Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.K242360Speedex 轻型体；Speedex 中型；Speedex 灰泥；Speedex 灰泥软；Speedex 通用激活器Dent4you AG
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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